The Department of Justice cleared yet another hurdle for Cigna to acquire PBM Express Scripts. FDA Commissioner Scott Gottlieb took aim at the CEO of a drug company, taking to social media to make add his comments to the ongoing dialogue on high drug costs. All across America, high prescription drug costs – and what to do about them – are in the news. A look at this week’s headlines in the Innovation Partners BioBlog.

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DOJ clears Cigna’s planned acquisition of Express Scripts

The Department of Justice has cleared the way for Cigna’s acquisition of Express Scripts. The $67 billion acquisition has come under scrutiny but has passed all hurdles to date. The DOJ has waived the waiting period under the Hart-Scott-Rodino Antitrust Act to allow the nation’s largest pharmacy benefits management company to proceed with the plans. The deal is expected to close by the end of the year, with the combined entity taking the Cigna brand name.
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Trump Eyeing ‘Disruptive’ Changes to Drug Pricing, Health Secretary Says

Health and Human Services Secretary Alex Azar stated that the Trump Administration seeks “disruptive changes” in the way drugs are priced, according to Bloomberg sources. The Administration has taken aim at many aspects of the drug industry including the list prices of prescription drug. Azar also mentioned pharmacy benefits managers (PBMs) but was careful not to cite them as the sole party responsible for high costs. The Administration has yet to unveil a cohesive, comprehensive plan to tackle the problem on behalf of consumers.
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CBO: House GOP bill delaying key parts of ObamaCare will cost over $50 billion

The House GOP continues to push legislation that would delay key parts of the Affordable Care Act (ObamaCare), but if they do so, it is going to cost America greatly – to the tune of $51.6 billion. A report released by the Congressional Budget Office, a nonpartisan group, arrived just as the House plans to vote on legislation this week.
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Brainstorm Health: Gottlieb on Price Gouging, Opioid Prescriptions, AliveCor’s Bloodless Blood Test

FDA Commissioner Scott Gottlieb took a hard line against price gouging this week. Gottlieb made a surprise statement via social media against Nostrum Laboratories’ CEO who quipped he had a moral imperative to make as much money as possible on new drugs. Gottlieb’s response took followers by surprise. He has made controversial moves in the past to ease the drug approval process especially for generics to ease pricing concerns.
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States are trying to lower drug prices. Here’s how their efforts are being thwarted

Although the Trump Administration has been vocal about high drug prices, states aren’t waiting for the federal government to take action. Rather, several states are taking their own steps to curb rising prescription drug prices. Heavy opposition is making it difficult for them to make headway. States such as Massachusetts asked to decline coverage for drugs with limited clinical trial evidence in a move to curb Medicaid costs.
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CMS proposes rule to streamline Medicare compliance

CMS took the final step in the Patients Over Paperwork initiative this week, proposing that Medicare eliminated unnecessary, redundant, and excessive paperwork. Some outdated regulations, for example, create undue paperwork burdens on physicians. CMS projects $5.2 billion in total savings and 53 million hours of administrative burden eliminated if such rules are waived or eliminated.
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Medicare Advantage Plan Proposed Use Of Step Therapy For Part B Drugs

The Department of Health and Human Services Blueprint, published in May 2018, outlines a method by Medicare Advantage plans can use step therapy for physician-administered Part B drugs. Step therapy is a subset of prior authorization requirements for drugs that grants patients access to more costly treatments only if they have previously received and had a poor outcome on a lower-cost therapy. About 33% of Medicare beneficiaries are enrolled in Medicare Advantage plans. Step therapy remains controversial because it defers certain treatments. Doctors and patients are concerned that deferring certain treatments may be detrimental to people with life-threatening conditions.
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